The Vector âtransdermalâ option is a scam. Period. In fact, if you have promotional material from them claiming they transdermal version produces results, please send it to me so I can report them to the US Food and Drug Administration for adulteration and misbranding.
Hereâs the FDA waring letter to a similar scam device:
http://www.fda.gov/foi/warning_letters/g4959d.htm
The Super Phaser Gold System with Transdermal Probes and Trancutaneous Patches is adulterated under section 501(f)(1)(B) in that it is a Class III device under section 513(f) and does not have an approved application for premarket approval in effect pursuant to section 515(a), or an approved application for an investigational device exemption under section 520(g).
The device is also misbranded under Section 502(0) in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k) and 21 CFR 807.81(a) (3) (ii). The Center for Devices and Radiological Health (CDRH) has not cleared patch or probe epilators for any indication.
For a product requiring premarket approval before marketing, the notification required by section 510(k) of the act is deemed to be satisfied when a premarket approval application (PMA) is pending before the agency, 21 CFR 807.81(b).
In 1995, American Hair Removal Systems, a company you were previously affiliated with, submitted a 510 ( k ) [redacted] for the AHRS Surface Electrolysis System, a modified patch epilator device that you apparently understood to require FDA clearance. However, CDRHâs Office of Device Evaluation (ODE) had numerous unanswered questions and could not clear the device. Your device applies diffuse energy to the site, whereas needle and tweezer epilators apply directed energy. CDRHâs ODE indicated a new protocol should be developed and sent you a [redacted] letter, notifying you that your submission was being withdrawn from the system and that all information should be re-submitted. FDA received no response to that notification.
Subsequently, absent FDA clearance, you marketed the device along with claims that the device is FDA cleared or approved. Appropriate data has not been submitted to support claims of no risk of infection, changes of pigmentation, no bruising, no scabbing, or no scarring, or that the procedure is painless. We have requested evidence to support these claims on several occasions but no information has been received from your firm.
Spare yourself a lot of wasted time. The patches have not been shown to work as claimed.